MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMWEAR FULL FACE MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Lot Number 030335389

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Blister (4537)

Event Date 02/03/2022

Event Type  Injury  

Manufacturer Narrative

User is still wearing mask and headgear.

Event Description

The manufacturer became aware of an allegation from a user's mother that she developed a rash with blistering where the mask and headgear are on her head about a year ago.The user has visited the dermatologist and has been prescribed antibiotics and prescription creams.The dermatitis remains and she currently is still using the mask and not taking any medication.The manufacturer suggested to the user switching masks and to wash her mask and headgear more frequently with detergent and air dry.The dermatologist will be testing for silicon reaction.No product will be returning.This is an initial-final report.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

Manufacturer Narrative

The manufacturer previously reported an allegation from a user's mother that she developed a rash with blistering where the mask and headgear are on her head about a year ago.The user has visited the dermatologist and has been prescribed antibiotics and prescription creams.The dermatitis remains and she currently is still using the mask and not taking any medication.The manufacturer suggested to the user switching masks and to wash her mask and headgear more frequently with detergent and air dry.The dermatologist will be testing for silicon reaction.No product will be returning.This is an initial-final report.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Additionally, three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.In the previous report, section h1 type of reportable event, was inadvertently selected as "other".It has been corrected to "serious injury" on this report.The manufacturer site is also corrected on this report in sections d3 and g1.

• Brand Name: DREAMWEAR FULL FACE MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16385208
• MDR Text Key: 309647843
• Report Number: 2518422-2023-04940
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 030335389
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Female